May 23 (Reuters) - Biohaven Pharmaceutical said on
Monday its experimental drug for patients with spinocerebellar
ataxia, a genetic disease that affects the nervous system,
failed to meet the main goal of a late-stage study.
Spinocerebellar ataxia (SCA) is a progressive disorder
caused by the degeneration of cells in the brain and spinal cord
and can lead to symptoms such as uncoordinated movement and
muscle wasting. It has no approved treatments in the United
States.
The main goal in the Biohaven study measured the change in
severity of symptoms among patients who took the drug,
troriluzole, from the baseline to week 48 of treatment.
Biohaven said patients in both the drug and placebo group
showed a less-than-expected change in disease progression, which
led to the study not reaching statistical significance.
But troriluzole showed some benefit compared with placebo in
patients with SCA Type 3 - the most common form of the disease,
Biohaven said.
The company plans to share the data on the subtype with
regulators and said it would work with the U.S. Food and Drug
Administration (FDA) on a path forward for the drug.
Biohaven earlier this month agreed to be bought by Pfizer
Inc in a $11.6 billion deal that underscored the buyer's
confidence in its commercial migraine drug.
Separately, the company said on Monday the U.S. FDA has
accepted the marketing application for its zavegepant nasal
spray to treat migraine in adults, with a decision expected in
the first quarter of 2023.
(Reporting by Leroy Leo and Amruta Khandekar in Bengaluru;
Editing by Aditya Soni)